The Genetics of Cardiomyopathy and Heart Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00703443
First received: June 19, 2008
Last updated: February 1, 2010
Last verified: April 2009
  Purpose

The purpose of this study is to determine the genetic basis of cardiomyopathies and heart failure.


Condition
Dilated Cardiomyopathy
Hypertrophic Cardiomyopathy
Mitochondrial Cardiomyopathy
Noncompaction Cardiomyopathy
Restrictive Cardiomyopathy

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Retrospective
Official Title: The Genetics of Cardiomyopathy and Heart Failure

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Biospecimen Retention:   Samples With DNA

Whole blood, Saliva, Buccal cells


Estimated Enrollment: 200
Study Start Date: April 2007
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of this research study is to explore the causes and inheritances of cardiomyopathies. Cardiomyopathies are serious medical conditions that result in a wide range of cardiac problems, from no symptoms at all to heart failure. The underlying genetics of cardiomyopathies are poorly understood. This study will collect personal, family, and medical history information to create a database of participants with cardiomyopathies. This information will be used to identify inheritance patterns within families with cardiomyopathies. In addition, samples from participants will be studied in the lab to see if any changes in their genetic information can be identified that would cause a cardiomyopathy. Overall, the research study is aimed at determining the cause of these cardiac conditions so that tests and treatments might be developed in the future.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We are recruiting both local participants (who have been evaluated at UCI) and remote participants (who have been referred from outside UCI) with familial and simplex cases of hypertrophic, dilated, noncompaction, restrictive, and mitochondrial cardiomyopathies. As a control group, we are also recruiting patients with nuclear mutations known to increase the risk of cardiomyopathy, but who have not themselves developed cardiomyopathy.

Criteria

Inclusion Criteria:

  • Individuals with a diagnosis of cardiomyopathy
  • Family members of individuals with a diagnosis of cardiomyopathy
  • Individuals with a nuclear mutation shown to confer risk of cardiomyopathy but who do not themselves have cardiomyopathy

Exclusion Criteria:

  • Individuals who do not have cardiomyopathy, a relative with cardiomyopathy, or a nuclear mutation predisposing to cardiomyopathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703443

Locations
United States, California
University of California, Irvine
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Michael V Zaragoza, M.D., Ph.D. University of California, Irvine
  More Information

Publications:
Responsible Party: Michael V. Zaragoza, M.D., Ph.D., Assistant Clinical Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00703443     History of Changes
Other Study ID Numbers: HS# 2007-5577, NIH/NHLBI 5K08HL081222-02
Study First Received: June 19, 2008
Last Updated: February 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Genetics
Dilated Cardiomyopathy
Hypertrophic Cardiomyopathy
Mitochondrial Cardiomyopathy
Noncompaction Cardiomyopathy
Restrictive Cardiomyopathy
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Dilated
Cardiomyopathy, Hypertrophic
Cardiomyopathy, Restrictive
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases

ClinicalTrials.gov processed this record on September 22, 2014